Comparing monitoring strategies for patients with new left bundle branch block after heart valve surgery

Comparison of a Clinical Monitoring Strategy Versus Electrophysiology-guided Algorithmic Approach in Patients With a New Left Bundle Branch Block After Transcatheter Aortic Valve Implantation (TAVI) a Bayesian Randomized Trial (COME-TAVI)

This study is testing if a new monitoring method can help people who develop a heart condition after valve surgery feel better and avoid serious problems like fainting or hospitalization.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 250 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Montreal Heart Institute (other)
• Locations: 10 sites (Edmonton, Alberta and 9 other locations)
• Trial ID: NCT03303612 on ClinicalTrials.gov

What this trial studies

This study investigates whether an electrophysiology-guided algorithmic approach is more effective than standard clinical follow-up in managing patients who develop new left bundle branch block (LBBB) after transcatheter aortic valve implantation (TAVI). Patients aged 18 and older without prior pacemakers will be randomized into two groups: one receiving the electrophysiology-based approach and the other undergoing standard monitoring. The primary goal is to reduce the incidence of syncope, hospitalization, and death in this patient population. Participants will be monitored for 30 days post-implantation to assess outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who develop persistent new-onset LBBB following TAVI and do not have a history of pacemaker implantation.

Not a fit: Patients with prior pacemaker or implantable cardioverter-defibrillator, or those with pre-existing bundle branch blocks will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved management and outcomes for patients experiencing new LBBB after TAVI.

How similar studies have performed: While the specific approach may be novel, similar studies have shown promise in improving outcomes for patients with cardiac conduction issues.

Eligibility criteria

Inclusion Criteria:

* Age ≥18 years
* Informed consent to participate
* Persistent new-onset LBBB after TAVI implantation (i.e. present at day 2)

Exclusion Criteria:

* Prior pacemaker or implantable cardioverter-defibrillator
* Pre-existing right bundle branch block (RBBB) or LBBB (i.e., prior to TAVI)
* Class I or IIA indication for PPM implantation according to management guidelines

Where this trial is running

Edmonton, Alberta and 9 other locations

• Mazankowski Alberta Heart Institute — Edmonton, Alberta, Canada (RECRUITING)
• New Brunswick Heart Center — Saint John, New Brunswick, Canada (NOT_YET_RECRUITING)
• QEII Health Sciences Center — Halifax, Nova Scotia, Canada (RECRUITING)
• Hamilton Health Sciences Corporation — Hamilton, Ontario, Canada (RECRUITING)
• London Health Sciences Center (LHSC) — London, Ontario, Canada (RECRUITING)
• University of Ottawa Heart Institute (UOHI) — Ottawa, Ontario, Canada (RECRUITING)
• Montreal Heart Institute — Montreal, Quebec, Canada (RECRUITING)
• CIUSSS du Nord de l'Île de Mtl — Montreal, Quebec, Canada (RECRUITING)
• Centre hospitalier universitaire de Sherbrooke — Sherbrooke, Quebec, Canada, Canada (RECRUITING)
• Centre Hospitalier Universitaire de Nantes — Nantes, Cedex 01, France (NOT_YET_RECRUITING)

Study contacts

• Principal investigator: Léna Rivard, MD, MSC — Montreal Heart Institute
• Study coordinator: Léna Rivard, MD, MSc

Conditions: Left Bundle-Branch Block, Aortic Valve Stenosis